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Proceedings Paper

Electrosurgical injuries during robot assisted surgery: insights from the FDA MAUDE database
Author(s): Andrew Fuller; George A. Vilos; Stephen E. Pautler
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Paper Abstract

Introduction: The da Vinci surgical system requires the use of electrosurgical instruments. The re-use of such instruments creates the potential for stray electrical currents from capacitive coupling and/or insulation failure with subsequent injury. The morbidity of such injuries may negate many of the benefits of minimally invasive surgery. We sought to evaluate the rate and nature of electrosurgical injury (ESI) associated with this device. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database is administered by the US Food and Drug Administration (FDA) and reports adverse events related to medical devices in the United States. We analyzed all incidents in the context of robotic surgery between January 2001 and June 2011 to identify those related to the use of electrosurgery. Results: In the past decade, a total of 605 reports have been submitted to the FDA with regard to adverse events related to the da Vinci robotic surgical platform. Of these, 24 (3.9%) were related to potential or actual ESI. Nine out of the 24 cases (37.5%) resulted in additional surgical intervention for repair. There were 6 bowel injuries of which only one was recognized and managed intra-operatively. The remainder required laparotomy between 5 and 8 days after the initial robotic procedure. Additionally, there were 3 skin burns. The remaining cases required conservative management or resulted in no harm. Conclusion: ESI in the context of robotic surgery is uncommon but remains under-recognized and under-reported. Surgeons performing robot assisted surgery should be aware that ESI can occur with robotic instruments and vigilance for intra- and post-operative complications is paramount.

Paper Details

Date Published: 9 February 2012
PDF: 6 pages
Proc. SPIE 8207, Photonic Therapeutics and Diagnostics VIII, 820714 (9 February 2012); doi: 10.1117/12.909456
Show Author Affiliations
Andrew Fuller, The Univ. of Western Ontario (Canada)
George A. Vilos, The Univ. of Western Ontario (Canada)
Stephen E. Pautler, The Univ. of Western Ontario (Canada)


Published in SPIE Proceedings Vol. 8207:
Photonic Therapeutics and Diagnostics VIII
Anita Mahadevan-Jansen; E. Duco Jansen; Andreas Mandelis; Kenton W. Gregory; Guillermo J. Tearney; Laura Marcu; Nikiforos Kollias; Bernard Choi; Haishan Zeng; Melissa J. Suter; Stephen Lam; Matthew Brenner; Hyun Wook Kang; Bodo E. Knudsen; Henry Hirschberg; Steen Madsen; Brian Jet-Fei Wong; Justus F. Ilgner; Krzysztof Izdebski, Editor(s)

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